MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30210

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Vascular Dissection (3160)

Event Date 03/14/2023

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported during a post-procedure follow-up for a basilar artery- superior cerebellar artery (ba-sca) aneurysm treatment, the patient required revision due to acute dissection caused by aneurysmal enlargement.There was no change in marker position of the subject stent and the struts were visible; however, the stent struts appeared to have spread widely with possibility of entering the aneurysm.The physician suspected the subject stent crown junction was fractured and implanted a new stent along with additional coils to complete re-treatment successfully.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that preoperative examination suspected dissection of the stent strut that had been implanted.Stent implanted in the basilar artery (ba) and superior cerebellar artery (sca) showed no change in marker position with postoperative course, and struts were visible.However, the stent struts appeared to spread widely where the stent was entering the mass, and the stent struts could not be seen inside the mass.When re-treatment was performed, the microcatheter was guided to re-implant the stent into the ba-sca, but when the micro guidewire was entered the mass, the wire behaved freely, and although the stent would normally have limited the wire behavior, it did not, so it was confident of dissection.After re-implanting the stent, five more coils were added, and the treatment was successfully completed.Additional information provided by the customer indicates that the device was prepared as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.According to doctor's opinion, the stent was pulled out by the sudden growth of the aneurysm and acute dissection, and the stent was exposed to strong blood flow in that condition, which may have caused the stent crown junction to break off.An assignable cause of procedural factors was assigned to this complaint, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

Event Description

It was reported during a post-procedure follow-up for a basilar artery- superior cerebellar artery (ba-sca) aneurysm treatment, the patient required revision due to acute dissection caused by aneurysmal enlargement.There was no change in marker position of the subject stent and the struts were visible; however, the stent struts appeared to have spread widely with possibility of entering the aneurysm.The physician suspected the subject stent crown junction was fractured and implanted a new stent along with additional coils to complete re-treatment successfully.Additional information received on 17-march-2023 confirmed that the stent (subject device) was dislodged/migrated from the target site where it was deployed.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16681340
• MDR Text Key: 312683607
• Report Number: 3008881809-2023-00173
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30210
• Device Lot Number: 23455894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (UNKNOWN); SL-10 MICROCATHETER (STRYKER); TARGET COILS (STRYKER)
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 21 YR
• Patient Sex: Female